September 2015

Erika Huffman, MSBME, RAC, Principal Medical Research Manager, NAMSA


Prior to submitting an investigational device exemption (IDE) application or other premarket submission, the US Food and Drug Administration (FDA) recommends using the Pre-Submission (Pre-Sub) program to obtain feedback on the submission. This process can be useful for novel devices and device sponsors who are new to premarket submissions.

The pre-IDE program was first established in 1995 to provide feedback on IDE submissions and has become the most commonly used method of obtaining FDA feedback prior to a premarket device submission.